Comparing induction of labor versus expectant management for gestational diabetes
The Feasibility Of Expectant Management Versus Induction At 38 Weeks Among Individuals With Gestational Diabetes Mellitus: A Randomized Controlled Pilot Trial
NA · Ottawa Hospital Research Institute · NCT06641141
This study is testing if inducing labor at 38 weeks for people with gestational diabetes can lower the chances of serious complications for their babies compared to waiting for labor to start on its own.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 260 (estimated) |
| Ages | 16 Years and up |
| Sex | Female |
| Sponsor | Ottawa Hospital Research Institute (other) |
| Locations | 1 site (Ottawa, Ontario) |
| Trial ID | NCT06641141 on ClinicalTrials.gov |
What this trial studies
This pilot trial aims to evaluate the feasibility of a multicenter randomized controlled approach to determine if inducing labor at 38 weeks for individuals with gestational diabetes mellitus (GDM) can reduce severe perinatal complications compared to expectant management. Participants will be recruited between 36 and 38 weeks of gestation and randomly assigned to either induction of labor or expectant management until spontaneous labor. The study will involve three visits: enrollment and randomization, postpartum assessment, and a follow-up at six weeks postpartum.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with gestational diabetes between 24 weeks and 38 weeks of gestation, with a singleton fetus and planning to deliver at a participating site.
Not a fit: Patients with pre-existing diabetes or those requiring immediate delivery due to obstetrical complications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into optimal management strategies for individuals with gestational diabetes, potentially improving maternal and neonatal outcomes.
How similar studies have performed: While this approach is being explored in this pilot trial, similar studies have shown varying results regarding the timing of labor induction in gestational diabetes management.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of GDM after 24 weeks of gestation, based on documented 1-step or 2-step screening and diagnostic tests for GDM. * Singleton fetus at randomization. * Confirmed live fetus within 24 hours prior to randomization. * Gestational age between 36 weeks + 0 days and 38 weeks + 0 days inclusive based on an ultrasound in the first or second trimester \[≤ 23 weeks + 0 days\]. For pregnancies conceived by in vitro fertilization, dating will be based on the embryo age at transfer. * Cephalic presentation. * Planning to deliver at a participating site. * Aged 16 years or older. Exclusion Criteria: * Pre-pregnancy diabetes mellitus. * Any obstetrical/maternal indication for immediate delivery including placenta abruption, abnormal fetal well-being either by non-stress test or biophysical profile, history of venous thromboembolism (VTE) on low molecular weight heparin, pre-existing hypertension, gestational hypertension, preeclampsia, eclampsia, or Hemolysis, elevated liver enzymes and low platelets (HELLP) syndrome at the time of randomization. * Contraindication to labour and/or vaginal delivery. * Signs of labour (regular uterine contractions accompanied by cervical dilation and/or effacement) at the time of randomization. * Significant vaginal bleeding or ruptured membranes at the time of randomization. * Prior Cesarean delivery. * Placenta previa, placenta accreta, or vasa previa. * Cerclage in current pregnancy. * Known major fetal anomaly (e.g., gastroschisis, congenital heart defects). * Known oligohydramnios (AFI \< 5 or MVP \< 2 or no 2 by 2 pocket). * Known fetal growth restriction (EFW \< 3rd percentile). * Refusal of blood products. * Use of unregulated substances.
Where this trial is running
Ottawa, Ontario
- The Ottawa Hospital — Ottawa, Ontario, Canada (RECRUITING)
Study contacts
- Principal investigator: Mark C Walker, MD, MSc, MHM — Ottawa Hospital Research Institute
- Study coordinator: Malia Murphy, PhD
- Email: malmurphy@ohri.ca
- Phone: 613-737-8899
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Gestational Diabetes Mellitus, gestational diabetes mellitus, gestational diabetes, induction, induction of labour